Dosage and Regimen Options

Dosages

There are two strengths of CombiPatch which are available by prescription only:
  1. A 9 cm² patch delivering 0.05 mg of estradiol and 0.14 mg of norethindrone acetate per day. This is also called 50/140 mcg.

  2. A 16 cm² patch delivering 0.05 mg of estradiol and 0.25 mg of norethindrone acetate per day for patients who require more progestin. This is also called 50/250 mcg.
Regimens

There are two treatment regimens for CombiPatch:
  • A continuous combined regimen (using only CombiPatch) to achieve amenorrhea.

  • A continuous cyclic regimen (using CombiPatch in combination with an estrogen-only treatment, such as Vivelle-Dot™ (estradiol transdermal system)) for a predictable monthly bleed. For important safety information about Vivelle-Dot, click here.
The 9 cm² CombiPatch 50/140 Dose The 16 cm² CombiPatch 50/250 Dose
9 cm² CombiPatch 50/140 Dose 16 cm² CombiPatch 50/250 Dose


Patches shown are not actual size, but are proportionally accurate.

Read more about choosing the appropriate treatment regimen.

CombiPatch Prescribing Information PDF

Vivelle-Dot Prescribing Information PDF

Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus MPA relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of oral conjugated estrogens with MPA, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogens and estrogens/progestins combined should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In clinical trials with CombiPatch, the most common side effects were breast pain, dysmenorrhea, and headache.

CombiPatch is indicated for women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, and moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Estrogens increase the risk of endometrial cancer. Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older.

Other doses of oral conjugated estrogens with MPA, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogens should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In clinical trials with Vivelle® (estradiol transdermal system), the most common side effects were headache, breast tenderness, and back pain.

Vivelle-DotTM and Vivelle are indicated for the treatment of the following conditions associated with menopause: moderate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; and the prevention of postmenopausal osteoporosis. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Vivelle-Dot 0.025 mg/day is indicated for the prevention of postmenopausal osteoporosis only. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis after non-estrogen medications have been carefully considered.



The information contained within this web site is appropriate for U.S. healthcare professionals only.

Available by prescription only.

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